FDA Registration
Active
🇺🇸 United States
Premiere Pneumatic Fracture Walker
Reg #: 2028810
·
FEI: 1000135616
·
Expires 2025
Products
1
Proprietary Names
11
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- ELITE ORTHOPAEDICS, INC.
- Registration Number
- 2028810
- FEI Number
- 1000135616
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1535 SANTA ANITA AVE.
- City
- South El Monte
- State
- CA
- ZIP
- 91733
- Country
- US
Owner / Operator
- Firm Name
- ELITE ORTHOPAEDICS, INC.
- Operator Number
- 9006401
- Address
- 1535 Santa Anita Avenue, --
- City
- South El Monte
- State
- CA
- Postal Code
- 91733
- Country
- US
- Correspondent
- Christine - Chang
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 1995-09-20 |
Proprietary Names
Premiere Pneumatic Fracture Walker
FS Walker
Premiere Fracture Walker
Advantage I Walker
FS Air Walker
Advantage II Walker
Pediatric Fracture Walker
Lace Up Ankle Brace
AirVantage Pneumatic Walker
Advantage I Pneumatic Walker
Deluxe Lace Up Ankle Brace
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device